1. Field of the Invention
The present description relates to a method and an apparatus for nondestructive testing of the integrity of flexible containers, in particular bioreactor containers.
2. Description of the Related Art
In the pharmaceutical and biotechnology industries, flexible containers, for example bags, are used as bioreactor containers for processing or storage. The containers may become damaged before actual use by the production process, transport or handling. It is therefore recommendable to carry out an integrity test of the container before actual use.
Conventional test methods for testing the integrity of the container are the pressure drop method, flow measurement and trace gas analysis with the use of a test gas. A common feature of all the test methods is that a pressure difference is generated between the interior of the container and a test apparatus containing the container, or the surroundings of the container. To this end, after production, or before and/or after use, the container to be tested is arranged in a test apparatus for testing the integrity, which generally has two plates separated from one another, between which the flexible container is arranged. The plates prevent uncontrolled expansion of the flexible container during the test. Instead, the container cannot expand beyond a volume predetermined by the plates. It is to be understood that the plates must be dimensioned according to the size of the container, so that the container remains fully between the plates even during the test.
It is an object of the invention to provide a method and an apparatus for testing the integrity of flexible containers, which allow improved integrity testing of the container.
The object is achieved by a method as claimed in claim 1 and by an apparatus as claimed in claim 4. Preferred embodiments are the subject-matter of the dependent claims.